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NCT01721057 · OUTCOME

Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries

A Study in Moderate to Severe Rheumatoid Arthritis Participants · Source last updated 2019-09-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Week 12

What was measured

Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.

Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.

Groups in this outcome

Placebo

Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg

Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo221
Baricitinib 2 mg223
Baricitinib 4 mg222

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo4.72.2Not reportedNot reportedNot reported
Baricitinib 2 mg3.92.5Not reportedNot reportedNot reported
Baricitinib 4 mg3.82.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.2
        value
        4.7
      2. group Id
        OG001
        spread
        2.5
        value
        3.9
      3. group Id
        OG002
        spread
        2.2
        value
        3.8
denoms
  1. counts
    1. group Id
      OG000
      value
      221
    2. group Id
      OG001
      value
      223
    3. group Id
      OG002
      value
      222
    units
    Participants
description
Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.
dispersion Type
Standard Deviation
groups
  1. description
    Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
    id
    OG000
    title
    Placebo
  2. description
    Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
    id
    OG001
    title
    Baricitinib 2 mg
  3. description
    Baricitinib 4 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
    id
    OG002
    title
    Baricitinib 4 mg
param Type
MEAN
population Description
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
reporting Status
POSTED
time Frame
Week 12
title
Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice